Brain Injury Biomarkers in the General Population

January 30, 2017 updated by: Banyan Biomarkers, Inc
The purpose of this study is to use an investigational assay to assess levels of putative biomarkers of traumatic brain injury (TBI) in a general population. The data will be used in a correlative analysis with data collected under a separate study of severe TBI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Vista, California, United States, 92083
        • Office of Nagi S. Ibrahim
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands at University Florida Gainesville
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Dekalb Medical Center
      • Lawrenceville, Georgia, United States, 30045
        • Gwinnett Medical Center
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • New England Center for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers who meet eligibility criteria

Description

Inclusion Criteria:

  • At least 18 years of age and no more than 80 years of age
  • Willing to undergo consent
  • PI believes volunteer is appropriate candidate for study

Exclusion Criteria:

  • Participating in another clinical study that may affect the results of either study
  • Non-English speaking
  • Venipuncture not feasible
  • Blood donation within 1 week of screening
  • PI determines volunteer is not medically suitable for study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Volunteers
Other: Blood draw at Days 0, 7, 14, and 21

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the putative biomarkers for TBI markers in general population using an investigational assay
Time Frame: up to 21 days
up to 21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of the putative biomarkers for TBI levels in general population to levels in patients with severe TBI
Time Frame: 0, 14, 7, and 21 days
0, 14, 7, and 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banyan Biomarkers, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 7, 2013

First Posted (Estimate)

February 8, 2013

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATO-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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